Technology-Enabled Care Model for Post-COVID Syndrome

(LC&FIRP Trial)

Overseen By Jane Samaniego, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Family Health Centers of San Diego

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new care program for individuals with Long COVID, Chronic Fatigue Syndrome, and similar conditions. The goal is to evaluate the effectiveness of a technology-enabled care model, known as Extension for Community Healthcare Outcomes, in improving health outcomes for these patients. The trial includes two groups: one participates in weekly online sessions and monthly webinars, while the other attends only monthly webinars and quarterly courses. Clinicians working with patients who experience ongoing symptoms and reduced quality of life due to these conditions are well-suited for this trial. As an unphased trial, this study offers patients the chance to contribute to innovative care models that could enhance their quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this care model is safe for patients?

Research has shown that the Extension for Community Healthcare Outcomes (ECHO) model has been adapted to manage healthcare needs during the COVID-19 pandemic. This model bridges healthcare gaps, especially in areas with limited medical access. Studies have found that telehealth methods like ECHO can treat various conditions, including Long COVID and other fatigue-related illnesses.

The ECHO model involves healthcare professionals collaborating in teams to share knowledge and provide care, leading to better patient outcomes. Reports have not indicated any serious safety issues with this model. Instead, it focuses on enhancing healthcare providers' skills through education and training.

While ECHO itself does not pose direct safety risks to patients, researchers continue to study the effectiveness of care provided using this model, particularly for conditions like Long COVID. Overall, the ECHO model is considered safe as it primarily serves as a support tool for healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a technology-enabled care model specifically designed for post-COVID syndrome, which often lacks standardized treatment protocols. Unlike traditional care options that might involve isolated therapies or medications, this model leverages weekly teleECHO sessions, monthly webinars, and quarterly short courses to provide continuous, interactive learning for healthcare providers. This approach not only aims to rapidly disseminate emerging best practices but also fosters a community of knowledge-sharing, potentially leading to more effective and personalized care for patients. By connecting experts and caregivers in real-time, this trial could establish a new standard for treating post-COVID syndrome, enhancing both provider education and patient outcomes.

What evidence suggests that this trial's treatments could be effective for Long COVID?

Research has shown that the ECHO model is a promising way to manage complex health issues like Long COVID. In this trial, participants in the Intervention arm will engage in weekly teleECHO sessions. These sessions use telehealth to connect local doctors with specialists, enhancing case management and sharing best practices. Early results suggest that ECHO can improve health outcomes by equipping doctors with the necessary tools for challenging cases. This model has already proven useful in other areas, such as schools and children's healthcare, supporting its potential effectiveness for Long COVID and similar conditions. Meanwhile, the Control arm will participate in monthly interactive webinars and quarterly short courses to disseminate findings and emerging best practices. ^{2 6 7 8 9}

Who Is on the Research Team?

Job Godino, PhD

Principal Investigator

Family Health Centers of San Diego

Christian Ramers, MD

Principal Investigator

Family Health Centers of San Diego

Are You a Good Fit for This Trial?

This trial is for licensed primary care physicians, physician assistants, or nurse practitioners at the Family Health Center of San Diego who treat patients with long-lasting symptoms and reduced quality of life due to Long COVID, Chronic Fatigue Syndrome (ME/CFS), or other post-infectious fatiguing illnesses. Participants must be willing to engage in a teleECHO program.

Inclusion Criteria

I have ongoing symptoms and my quality of life has declined due to long COVID or similar conditions.

I care for patients with long-term symptoms from PASC, ME/CFS, or OPIFI.

Clinicians must be a licensed primary care physician, physician assistant, or nurse practitioner

Exclusion Criteria

There are no exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians participate in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses

37 months

Weekly sessions, monthly webinars, quarterly courses

Control

Clinicians participate in monthly interactive webinars and quarterly short courses

37 months

Monthly webinars, quarterly courses

Follow-up

Participants are monitored for outcomes at various intervals post-baseline

37 months

Quarterly follow-up surveys

What Are the Treatments Tested in This Trial?

Interventions

• Extension for Community Healthcare Outcomes

Trial Overview The study tests the effectiveness of a multi-disciplinary team-based care model via teleECHO for managing complex cases related to Long COVID and similar conditions. It aims to improve clinical outcomes and assess the feasibility and sustainability of such programs in community healthcare settings.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.

Group II: Control Active Control 1 Intervention

The Control arm participates in monthly interactive webinars and quarterly short courses. Monthly interactive webinars will offer brief didactic presentations by SMEs, examples of models of care, and a facilitated Q\&A. These webinars will be convened to rapidly disseminate findings and emerging best practices to a large-scale, national audience. Quarterly short courses will be developed to summarize key findings from past weekly teleECHO sessions. These quarterly short courses will be formatted as a learning module with the use of presentation slides and videos online that are accessible asynchronously.

Who Is Running the Clinical Trial?

Family Health Centers of San Diego

Lead Sponsor

Trials

9

Recruited

15,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556453/

COVID Just-in-Time Extension for Community Health ... This study aimed to determine the value of the COVID Just-in-Time ECHO (Extension for Community Health Outcomes) Learning Series for Schools.

2. tandfonline.com tandfonline.com/doi/full/10.1080/22423982.2023.2244768

Use of the Extension for Community Health Outcomes ... Project ECHO (Extension for Community Healthcare Outcomes) is a telehealth and virtual mentoring model. It is a scalable platform to create ...

3. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/project-echo-extension-community-healthcare-outcomes

Project ECHO: Extension for Community Healthcare ... This model focused on the principles of case-based learning and disease management using the telemedicine infrastructure and internet-based technologies to co- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10423413/

A technology-enabled multi-disciplinary team-based care ... We aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/00099228251323396

Enhancing Pediatric Long COVID Care Through ... Project ECHO (Extension for Community Healthcare Outcomes) is an innovative model for mentoring community providers in diagnosing and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10416732/

Use of the Extension for Community Health Outcomes (ECHO ... The Project ECHO model is designed to help bridge healthcare gaps caused by isolation, distance, and lack of access. The COVID-19 pandemic ...

7. ahrq.gov ahrq.gov/patient-safety/settings/multiple/project-echo/index.html

Project ECHO | Agency for Healthcare Research and Quality Adapting the Project ECHO model and using available telehealth methods can optimize community treatment of various conditions during the COVID-19 pandemic.

8. cdc.gov cdc.gov/lab-quality/php/echo/index.html

Project Extension for Community Healthcare Outcomes The ECHO (Extension for Community Healthcare Outcomes) Project was designed to educate and train laboratory and healthcare professionals on ...

9. iecho.org iecho.org/public/program/PRGM17586394861690YH6E16NHX

Comunidad Long COVID ECHO The Comunidad Long COVID ECHO program will support symptom-based assessments and share emerging evidence-based and consensus guidelines to improve coordination ...